Mouth guard and kit

ABSTRACT

A user-fabricated mouth guard wherein the user&#39;s teeth and gums are not directly exposed to the uncured mouth guard material. The uncured mouth guard material is pliant at room temperature and does not have to be heated to form and shape the mouth guard. The cured mouth guard call be pliant or rigid at room temperature. A kit and a method of forming the mouth guard are also disclosed.

BACKGROUND

1. Field of the Invention

The invention relates to the prevention of intraoral and tooth trauma.

2. State of the Art

Facial trauma experienced by athletes has been demonstrably reduced bythe use of a mouth guard during participation in athletic events. Thesemouth guards, or mouth protectors, provide protection against injuriesto the teeth, lips, cheeks, and gums, and may also reduce the incidenceof head and neck injuries, concussions, and jaw fractures.

A number of mouth guards currently exist in the art for protectingagainst the injuries described above. The American Society for Testingand Materials has classified mouth guards into three types: stock mouthguards, mouth-formed mouth guards, and custom-fabricated mouth guards.Some of these mouth guards are fitted with a tether or strap to connectthem to a fastening point, such as a helmet or the like, to preventloss, swallowing, or choking on the mouth guard by the user. Generally,mouth protectors are fabricated to cover all teeth of the maxillaryarch, except for the erupting third molars. To provide maximumprotection, it is believed that the energy absorbed by the mouthprotector must be dissipated by the protector, rather than transferredto the underlying tooth and jaw structure.

Stock mouth guards typically can be purchased at sporting goods stores,department stores, and pharmacies. These mouth guards may be made ofrubber, polyvinyl chloride, or polyvinyl acetate copolymer and aretypically available in small, medium, and large sizes. These stock mouthguards are not in any way molded or “fit” to the persons wearing themand, as a result, can be loose and uncomfortable for the user. Often themouth must be closed in order to hold them in place, and many athletesfind them bulky and uncomfortable. In addition, these mouth guards caninterfere with speech and breathing which is a further strongdisincentive for athletes to wear these mouth guards.

Mouth-formed mouth guards are fitted by the user. They are molded to fitthe individual wearer either by the use of a moldable inner linertypically of plasticized acrylic gel or silicone rubber, or the use of amoldable thermoplastic that softens when immersed in boiling water andre-hardens when cooled. The thermoplastic mouth guard is also known asthe “boil-and-bite” mouth guard. However, repeated biting duringparticipation in athletic events or gnawing due to nervousness before orduring an athletic event can cause the material to spread resulting in aloose fit. In addition, aging and/or continual exposure to oral fluidsmay cause the plasticizers to leach out causing the liner to becomehard. The method of forming these mouth guards can also be uncomfortableand difficult for a user to perform. Namely, the user is required toboil the guard for the prescribed amount of time and then insert the hotmaterial into the user's mouth and bite down on it, which can be veryuncomfortable. The quality of these mouth guards is clearly highlyuser-dependant.

Cook, U.S. Patent Application No. 2002/0144686, describes a “soft”boil-and-bite type of mouth guard. Instead of being made of thetraditional ethylene/vinyl acetate (EVA) polymer, it is made of a softimpressionable low-density polyethylene. Wagner, U.S. Pat. No.5,566,684, describes a mouth guard made of a low softening temperaturethermoplastic (e.g., EVA) liner on top of a higher temperaturethermoplastic. It is described as a do-it-yourself mouth guard that isformable by the boil-and-bite technique. These mouth guards still sufferfrom the same disadvantages of traditional boil-and-bite guards.

Another mouth-formed guard is made in a dentist's office by impressingthe teeth directly onto an uncured ethyl methacrylate gel, which is laidinto all outer mouth guard shell/tray all of which becomes one device.Although the custom fit of the softer “lining” feels more comfortable,some users object to its taste and odor. Instructions for the use ofthese guards advise that the lining be replaced before every use, andthat the actual fitting be done by a dentist, hence, increasing the costof the guard.

Custom-made mouth guards are considered to be the best of theconventional mouth guards as far as fit, shape retention, and comfortare concerned, but they are also the most expensive. This type of mouthguard tends to be less bulky than the other two types and may stay inposition better. Custom mouth guards are typically composed of athermoplastic polymer, of which the most popular type is ethylene/vinylacetate copolymer, although acrylic resin, polyurethane, and variousrubber materials ale also used. Custom-made mouth guards are fabricatedby vacuum-drawing a thick thermoplastic film/sheet over a dental moldformed by standard dental impression techniques, and most often thisprocess is clone by a dentist or in a dental laboratory. There areusually four steps required in the making of a custom-fit mouthguard: 1) making an impression of the maxillary arch; 2) pouting a cast;3) forming the thermoplastic material on the cast; and 4) finishing theprotector. Because of the special technique used in the dental office,the guards are rather expensive, and still slightly uncomfortable due tothe rigidity of the thermoplastic used. Although these mouth guards arereusable, they cannot, ordinarily, be fabricated in the field.

The mouth guards described above are typically U-shaped to match thegeneral shape of the upper dental arch and have upward inner lingual andouter labial walls extending therefrom. Bi-maxillary mouth guards arealso available which have protection for both dental arches and hold themouth in a predetermined position to allow for maximum breathingcapability.

Jones et al., U.S. Pat. No. 5,746,221, teaches a mouth guard made ofpolytetrafluoroethylene or PTFE. The PTFE is cold formable thus it willmold to a user's teeth without being heated. However, the mouth guardsof Jones et al. do not cure but remain soft and are easily deformedduring use. In fact, Jones et al. teaches the mouth guards are“extremely resistant to hardening” (see col. 6, lines 46-48). A user'steeth and gums directly contact the mouth guard material which the usermay find unpleasant and foul tasting.

Going et al., U.S. Pat. No. 4,063,552, teaches a silicone based mouthguard. The mouth guard is formed by squeezing a polydimethyl siloxanematerial from a packet into a cylindrically shaped dough. The siliconedough is then placed on a U-shaped tray. A user inserts the tray intothe mouth and pushes the silicone dough upward to engage the upperteeth. The tray is then removed and the silicone is held in the mouthallowing it to cure. However, significant problems are encounteredbecause the silicone is applied directly to the user's teeth and gums.Firstly, the silicone is forced out above the upper tray edges by theteeth and gums. This material must be reapplied to, for example alongthe outside gum surfaces by smoothing it out with the index finger.Also, excess material must be removed. Secondly, the siliconesubstantially sticks to the tray making it very difficult to remove thetray from within the mouth. To remedy this, Going et al. teach a complextwo-part tray equipped with a release liner. Thirdly, undesiredchemicals may be absorbed by the user's gums or mucosa due to the directcontact with the uncured silicone, which could lead to skin lesions andrashes in the mouth. The user may also find direct contact with thesilicone paste (or putty) unpleasant, foul tasting, and unhygienic.

Fischer et al., U.S. Patent Application No. 2003/0145863, describes amethod of adding an extra cushioning layer to an existing mouth guard bydispensing a curable elastomeric material into the trough of the mouthguard. The device is then placed into a person's mouth to impress theteeth into the material and allowing it to cure, at least partiallywhile inside of the mouth. Fischer et al. discloses that a polysiloxanecan be used as the curable elastomeric material. This method suffersfrom many of the same disadvantages as that of Going et al. Namely,there is direct contact between the user's teeth and gums and the mouthguard material; and the extra cushioning layer material is not preventedfrom oozing out over the walls surrounding the trough of the mouthguard.

Adell, U.S. Pat. No. 4,955,393, teaches a mouth guard comprising a teethimpressionable liner. The liner can be made of urethanes, silicones, orvinyls and is less rigid than a trough material. A user bites down onthe liner, which begins to cure due to the water in a user's saliva. Theuser then removes the mouth guard and places it in water to complete thecuring process. This mouth guard suffers from the same problem of directcontact between the user's teeth and gums and the mouth guard material.

Adell, U.S. Pat. No. 5,406,963, teaches a similar mouth guard and itsmethod of manufacture. This mouth guard comprises a main body and atooth impressionable liner made of substantially the same material. Thematerials of the two parts differ only in durometer with the durometerof the main body material being higher than that of the liner material.This mouth guard still suffers from unpleasant direct contact betweenthe user's teeth and gums and the uncured mouth guard material.

Monagham, U.S. Pat. No. 3,224,443, teaches a method of forming a mouthguard comprising applying a fiber filled silicone putty directly to auser's teeth. The user then works the putty around the teeth using theirfingers and tongue and then bites down on the putty to form toothimpressions. The thus formed guard then cures in the mouth. Clearly, amouth guard formed by this method is prone to thickness differentialsand non-uniformities that could lead to injury while in use. Of course,this method also suffers from the problem of direct contact between thesilicone putty and the user's teeth and gums which in the extreme couldinclude swallowing and absorbing hazardous curing agents through thegums or mucosa of the user.

Fishman et al., U.S. Pat. No. 5,816,255, describes forming a mouth guardby a similar method except that a bite bar is utilized to hold theputty. A user first measures out equal amounts of a base putty and acatalyst putty. The user then mixes the putty together to form a curableputty. The user then rolls the curable putty into a cylindrically shapedmass and then curves the putty around the bite bar to form a generallyU-shaped putty. The putty is then inserted into the user's mouth and theuser bites down on the putty and allows it to cure. This mouth guardsuffers from the same non-uniformities and direct contact problems asthat taught by Monaghan. The method also suffers from relying on theuser to perform the cumbersome task of measuring equal amounts of thetwo putty. Thus, the method is time consuming, frustrating, and thequality of the finished mouth guard is highly user-dependant.

There remains a need for a high quality mouth guard that is relativelyinexpensive and readily user-formable. Specifically, there is a need fora user-formable mouth guard that does not require direct contact betweenthe user's teeth and gums, and the uncured mouth guard material.

SUMMARY

One embodiment of the invention is a mouth guard formed by a processwherein a user forms an impression of the user's own teeth in the mouthguard material without the user's teeth or gums being directly exposedto the mouth guard material.

Another embodiment of the invention is a kit for forming a mouth guard.The kit comprises a resin, a thin-walled film container, and a dentaltray. The tray and the container are sized to substantially correspondto a user's upper maxillary arch.

Another embodiment of the invention is a method for forming auser-fabricated mouth guard. A resin is provided into a thin-walledcontainer. The container is placed into a dental tray. The resin,container, and tray are inserted into a user's mouth. Impressions of theuser's teeth are formed in the resin. The resin is cured. The resin,container, and tray are removed from the user's mouth. The containermaterial is removed from around the cured resin to form a mouth guard.

Another embodiment of the invention is a method for forming a mouthguard. The method comprises forming a mouth guard by using a model of aperson's teeth. A resin is provided into a thin-walled container. Thecontainer is placed into a tray. The teeth of the model are impressedonto the resin-filled container. The resin is cured. The model of theperson's teeth is then lifted off the container. The container materialis removed from around the cured resin to form a mouth guard.

The accompanying drawings are for illustrative purposes only. Thedrawings are not drawn to scale and are not meant to limit the inventionin any manner. The scope and breadth of the invention is limited only bythe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of the thin-walled container of the presentinvention in an empty state.

FIG. 2 shows an embodiment of the device used to deliver resin to thecontainer.

FIG. 3 shows an embodiment of the resin-filled container of the presentinvention in a closed state.

FIG. 4 shows an embodiment of the resin-filled container placed on atray.

FIGS. 5 and 6 show embodiments of the cured mouth guard of the presentinvention surrounded by container material.

FIGS. 7 and 8 show different views of all embodiment of the cured mouthguard with the container material removed.

FIG. 9 shows a cross-sectional view, along the line A-A, of the mouthguard shown in FIG. 7.

DETAILED DESCRIPTION

The mouth guard of the present invention is a user-fabricated mouthguard made of a polymerizing resin. The mouth guard is formed by theuser impressing the user's own teeth into the resin without the user'steeth or gums directly contacting the resin.

The method of formation comprises injecting a polymerizable liquid resininto a thin-walled container; placing the container on a dental tray;inserting the tray into a user's mouth; forming impressions of theuser's teeth in the resin; curing the resin; removing the resin,container, and tray from the user's mouth; and removing the containermaterial from around the cured resin to form a mouth guard. This novelmouth guard can also be made by making the dental impression with astone model of the user's teeth. In either case, the user's teeth andoral tissues do not make direct contact with the uncured elastomericresin.

The mouth guard of the present invention is formed by the user via amouth guard kit. The kit comprises a resin delivery device containing aresin; a thin-walled container, and a tray.

Turning to FIG. 1, the container is preferably substantially U-shaped,can be made of a thin plastic film, and is open at one end for theintroduction of the resin. The container is more preferably a U-shapedplastic bag. The open end extends beyond the closed end of the bag andforms a filling neck. The shape and size of the bag is dictated by thesize of the tray that is to be used. Generally, the bag is “oversized”in that it is wider than the trough of the tray, and it has a U-shapedcurvature of a larger radius than that of the tray. The bag's shape andsize is matched to the design of the tray to be used, i.e., a differentbag/tray pair would be used for each of a small, a medium, and a largemouth guard. The bag is preferably made of a clear polyethylene filmwith a thickness of between about 0.0001 and 0.001 inches. Morepreferably the polyethylene film has a thickness of between about 0.0002and 0.0005 inches.

The tray is preferably a regular, inexpensive, plastic tray used indental offices for taking dental impressions. Preferably, the tray is aconventional dental tray. One embodiment of the dental tray is shown inFIG. 4. Such a tray is designed to fit into a person's mouth and conformto the person's upper maxillary arch. Although these trays are normallysold as disposable, for the purpose of the present invention, the trayis to be reusable. Preferably, the tray is of the non-perforated (solid)type. The tray can be of any size that generally corresponds to the sizeof a person's mouth and it must match with the appropriate size ofU-shaped bag. Any type of dental impression tray will work. In fact, anytray that serves the function and purpose of the tray used in thisinvention applies.

The resin preferably comprises a liquid, curable elastomeric rubber.More preferably the resin comprises a two-component silicone resin. Mostpreferably, the resin comprises one part resin and one part curlingagent, by volume. However, the ratio of the parts of the composition canbe other than 1-to-1, e.g., 1-to-2, 1-to-4, 1-to-10.

The choice of silicone rubber used is based on the intended use of themouth guard, which may call for different hardness or toughnesscharacteristics. Basically, any elastomeric composition which, whencured, is judged to be sufficiently strong to absorb and dissipate theenergy from a sport-type impact can be used.

Other resin compositions that could be used include curable liquidswhich, when fully curled, are semi-rigid, e.g., 1- or 2-partsolventless, liquid, curable compositions, such as polyurethanes,epoxies, polysulfides, and the like, and polyacrylics,poly(methacrylics), polyallylics, and like photocurables.

The resin is contained within a resin delivery device. Preferably, theresin delivery device is a one-dose syringe, since the range of thequantity needed in the bag is fairly narrow. Preferably, the syringecomprises two separate compartments and a stationary mixing tip. Oneexample of such a syringe is shown in FIG. 2. Such a syringe allows theresin and curing agent to be stored without reacting, and then bedelivered to the container when forming the mouth guard. The stationarymixing tip mixes the two components together and delivers a mixture ofresin and curing agent to the container. The resin immediately begins tocure after being mixed with the curing agent. Syringes comprising dualcartridges can also be used, but such syringes/cartridges wouldnecessitate a matching dispensing gun.

Method of User-Forming the Mouth Guard

A user first delivers the resin/curing agent mixture to the U-shapedbag. A user injects the liquid resin into the U-shaped bag by firstgathering the bag over the mixer tip, until the tip reaches the closedend of the bag, and then slowly withdrawing the bag from the mixer tipas the bag is being filled without entrapment of large air pockets. Theuser then preferably evenly distributes the resin throughout the bag bylaying the bag onto a work surface and lightly pressing on the bag untilit lays flat on the work surface, and all the residual air is displacedout of the bag. The user then closes the filled bag by folding over thefilling neck of the bag (once or twice), and leaving it folded under thebag. FIG. 3 shows an embodiment of a resin-filled bag in a closed state.

The user then places the flattened bag into the trough of the plasticdental tray, and again preferably presses lightly on the bag to achievean even distribution in the tray while insuring that the folded closurelies under the bag. FIG. 4 shows an embodiment of the folded bag placedon a dental tray. Preferably, the bag is positioned into the tray so asto allow the ends of the bag to hangover slightly over the edges of theopen ends of the tray.

The user then places the tray with the bag into the user's mouth, andpositions the tray to impress the user's upper teeth into the softresin-filled bag. The user then slowly impresses the teeth by impartinga relaxed yet firm biting pressure on the filled bag. Preferably, theuser's palate should just barely touch the palate part of the plastictray. The pressure forces the liquid resin, surrounded and confined bythe bag, to distribute into the unfilled spaces between it and the wallof the plastic tray. The user maintains constant teeth pressure for thetime necessary for curing the resin. Once cured, the user removes thetray with the shaped bag from the mouth and rinses both items. FIGS. 5and 6 show alternative views of the formed mouth guard before theU-shaped bag is removed with the filling neck in an unfolded state. Theuser then puts aside the tray for re-use, and removes the U-shaped bagfrom around the cured resin to yield a finished mouth guard. The bag ispreferably removed by a peeling action similar to peeling a shrimp.FIGS. 7 and 8 show alternative views of the formed mouth guard after theU-shaped bag has been removed. FIG. 9 shows a cross-sectional view ofthe finished mouth guard.

The pressure of the user's teeth on the bag forces theuncured/polymerizing resin into the spaces between the row of teeth andthe inside wall of the dental tray. Hence, once the resin is cured, thisconfirmation gives rise to the formation of the frontal and lateralwalls of the mouth guard, and its overall final shape. The thickness ofthe biting surfaces, as well as that of the frontal and lateral wall,depends on the dimensions of the bag and the amount of resin used in thebag. The thus formed mouth guard will lessen the risk of injury to theanterior maxillary teeth, lessen the risk of jaw fracture, and reducethe severity of craniofacial injuries, such as damage to the TMJ(temperomandibular joint).

The above description is just one specific embodiment of a method forforming the mouth guard of the present invention. In practice, certainsteps such as evenly distributing the resin throughout the bag can beomitted and other steps could be added. The steps can also be performedin any order as long as a cured mouth guard is obtained as the finalproduct. The method is exemplary only and is not meant to limit theinvention in any way.

EXAMPLES

Fabrication of the U-Shaped Bag

A 0.8-mil clear PE sandwich bag was used as the container startingmaterial. The sandwich bag was laid flat onto a sheet of paper, and avery hot wire which was bent to the shape corresponding to the contourof the desired U-shape was impressed onto the bag. The heat of the wirebonded the two film layers together, and helped “cut” the U-shaped bagaway from the rest of the sandwich bag.

Example 1

A tubular U-shaped thin-walled polyethylene bag was filled with 9.81grams of a 2-part, 1:1 liquid silicone resin (modified/fast SilpakR-2438™), dispensed from a 25 ml dual cartridge operated with a manuallyheld dispensing gun. As soon as the dispensing was completed, the bagwas laid on a work bench and the resin was pushed toward the opening ofthe bag so as to expel the air out of the bag. The filling end of thebag was then folded twice to effectively close the bag. While holdingthe folded end, the bag was then laid into the trough of a medium-sizeplastic dental impression tray. The folded closure of the bag was thentucked under the bag at the “open end” of the plastic tray. The bag waspressed gently, and briefly, to achieve an even distribution of theresin in the bag, and to fine-tune the positioning of the bag in thetrough.

The tray with the bag was then placed into the user's mouth with the bagfacing the upper teeth. The user's upper teeth were impressed carefullyinto the resin until a resistance was felt indicating that the bag andits contents “tightened up” and resisted further closing of the teeth.

The silicone resin was then allowed to cure while keeping the teethimpressed with a gentle yet firm pressure. Once cured, the tray and thebag containing the finished mouth guard were removed from the user'smouth and rinsed with warm tap water. The mouth guard was taken out ofthe bag by tearing off the thin polyethylene film. The film was disposedof and the tray was kept for re-use. The bite of the finished guard wasabout 3-4 mm, and the front inside wall of the guard was about 11-12 mmhigh. The filling and positioning took about 7 minutes and the totaltime for forming the guard was about 16 minutes.

Example 2

The procedure of Example 1 was carried out using 10.13 g of a 2-part,1:1 liquid silicone resin (Ecoflex 5™). The dental tray was slightlymodified at its open ends to see if it would make a difference in theclosing of the bag, and to see the effects on the dimensions of thefinal mouth guard. The folded-over closure of the bag did not leak. Thebite of the finished guard measured about 5-6 mm, and the front insidewall of the guard was about 9 mm high.

Example 3

Example 2 was carried out using 9.75 g of the same liquid siliconeresin, but using a standard medium-size dental impression tray. The biteof the finished guard measured about 3-4 mm, and the front inside wallof the guard was about 10-11 mm high.

Example 4

The procedure of Example 1 was carried out using 9.49 g of the siliconeresin, but instead of impressing the teeth by inserting the tray/baginto the mouth, a stone model of a set of upper teeth was impressed ontothe bag (while in the tray, resting on a bench top) and held down with a1.2 kg weight. The bite of the finished guard measured about 4-5 mm, andthe front inside wall of the guard was about 9-10 mm high.

Example 5

The procedure of Example 4 was carried out using 9.40 g of a 2-part, 1:1liquid silicone resin (Dragon Skin Q™). The bite of the finished guardmeasured about 4 mm, and the front inside wall of the guard was about10-11 mm high.

Example 6

The procedure of Example 5 was repeated but only 9.10 g of resin wasused. The bite of the finished guard measured about 3 mm, and the frontinside wall of the guard was about 10-12 mm high.

Example 7

The procedure of Example 5 was repeated using a larger-size bag. 13.61 gof a 2-part, 1:1 liquid silicon resin (modified/fast Silpack R-2458™)was used. The bite of the finished guard measured about 3-4 mm, and thefront inside wall of the guard was about 15 mm high.

Example 8

The procedure of Example 7 was repeated but a harder resin was used.13.60 g of a harder 2-part, 1:1 liquid silicon resin (Silpack R-2458SP™)was used. The bite of the finished guard measured about 3-4 mm, whilethe inside wall measured about 14-15 mm.

Example 9

The procedure of Example 4 was carried out using 11.69 g of 2-part, 1:1liquid polyurethane resin (APTEK 2206™). A weight of approximately 160 gwas used for holding down the stone model on the bag. As this resin wasnot designed for fast curing, it was allowed to cure overnight. Theresulting guard had a bite of about 3-4 mm, and an inside wall height ofabout 10 mm.

Example 10

The procedure of Example 4 was repeated using 10.40 g of a 2-part, 1:1all-purpose epoxy adhesive (Devcon™). As this resin was not designed forfast curing, it was allowed to cure for two hours. The resulting guardhad a bite of about 3 mm, and an inside wall height of about 10 mm.

The fabrication of the mouth guard of the present invention can beperformed at home or “on the field”. The guard is much more comfortableto wear than over-the-counter stock or boil-and-bite mouth guards, sincethe material of construction conforms well to the dental impression ofthe teeth. The cured elastomeric resin is also more compliant and gentlewhere it makes contact with the gum. The elastomeric compliance alsoprovides easy adaptation to minor imperfections that may result fromnormal shifting of teeth during normal growth of, for example, a younguser.

The thus formed mouth guard is uniform and closely matches the user'sown teeth. The user can then use the mouth guard for protectionespecially in athletic activities in which concussive blows to the headare administered such as boxing, football, and rugby. The mouth guard istasteless, odorless, reusable, and comparatively inexpensive.Optionally, flavors and colors can be introduced into the resin, and/orinto the film of the U-shaped bag. Also, optionally, various ingredients(e.g., antibacterials, antifungals, fluorides, etc,) can be introducedinto the resin to give the guard a therapeutic value.

The mouth guards described represent only exemplary embodiments of thisinvention and are meant in no way to limit the scope of the appendedclaims. Numerous modifications could be made without departing from theinstant inventive concept. For example, the U-shaped bag could be madeof a conformable thin elastomeric material. Such material should exhibita fairly low percentage of elongation so that it limits the amount ofstretching to just the desired boundary dictated by the mouth guarddesign. The bag could be made to contain items which will reinforce thefinal cured plastic/elastomeric material. For example, the bag could bestuffed with fibrous fillers of sufficient length to allow the injectedresin to freely flow within the bag, and “wet” the fibers/fillersthoroughly before curling completely. Such fibrous fillers couldinclude, e.g., low density felt and loosely woven or unwovenfibers/fabrics. A bag with a different closing method could also beused. For example, the “open” end of the bag could constitute a smallinjector-tip activated one-way valve.

The injectable elastomer could also include a time-delayed foamablematerial of acceptable toughness for the particular application. Theinjectable elastomer could also include light/radiation curablecompositions. These materials would be used for curing outside of theusers mouth (making use of a light-transparent model of his/her teeth),by placing the filled bag into the trough of a light-transparent tray,and then placing the bag with the mold into a small light-curing box. Ofcourse the user-formed embodiments could also include an external curingstep, such is, slight heating to speed up the curing.

Further, although the embodiments described are for protecting the upperteeth, this inventive process could also be used for lower maxillarymouth guards or bi-maxillary mouth guards.

Although particular embodiments of this invention have been disclosedherein for purposes of explanation, further modifications or variationsthereof will be apparent to those skilled in the art to which thisinvention pertains. Thus, the scope of the present invention is onlylimited by the appended claims.

1. A kit for forming a mouth guard, said kit comprising: a thin-walledcontainer; a curable resin; and a tray, wherein the tray is sized tosubstantially correspond to a person's upper maxillary arch and whereinthe container is sized to substantially fit on the dental tray.
 2. Thekit of claim 1, wherein the container comprises a polyethylene film. 3.The kit of claim 2, wherein the polyethylene film has a thickness ofbetween about 0.0001 and about 0.001 inches.
 4. The kit of claim 1,wherein the container is stuffed with fibrous fillers.
 5. The kit ofclaim 1, wherein the curable resin comprises a two-part resin.
 6. Thekit of claim 5, wherein the two-part resin comprises a silicone part anda catalytic silicone curing agent part.
 7. The kit of claim 6, whereinthe two parts are in a ratio of about 1 to about 1 by volume.
 8. The kitof claim 6, further comprising a device for delivering the two-partresin.
 9. The kit of claim 8, wherein the device comprises separatechambers for each part of the two-part resin, mixing means for mixingthe two parts together, and delivery means for delivering the mixedparts to the container.
 10. The kit of claim 9, wherein the devicecomprises a dual cartridge syringe.
 11. The kit of claim 1, wherein thethin-walled container is a bag.
 12. A user-fabricated mouth guardcomprising impressions formed by the user's own teeth wherein the user'sown teeth do not directly contact the mouth guard material during theformation of the impressions.
 13. The mouth guard of claim 12, whereinthe mouth guard material comprises elastomeric rubber.
 14. The mouthguard of claim 13, wherein the mouth guard material comprises a siliconeresin.
 15. The mouth guard of claim 14, wherein the mouth guard materialcomprises a material selected from the group consisting of: athermosetting resin, a polyurethane resin, and an epoxy adhesive. 16.The mouth guard of claim 15, wherein the mouth guard is formed withoutsubjecting the mouth guard material to a heating process external to theuser's mouth.